Patient Reported Outcomes

Group Leader: Dr Melanie Calvert

Overview

Patient reported outcomes (PROs) are measures reported directly by the patient, which provide “the patient voice” in clinical trials investigating evidence of treatment effectiveness. The aim of the PRO Research Group is to develop best practice for PRO use in trials, to improve the quality of PRO information collected, so that clinical care for patients may be better informed.

Our research group

PRO data may be used to inform clinical care and decision-making, predict long-term outcomes and inform health policy. Despite this, research suggests that the design, data collection, reporting and dissemination of PROs in trials are frequently suboptimal. These practices devalue important patient-centred data and limit the impact of PRO results in the clinical setting.

The PROs Research Group lead a programme of work, with international collaborators, aiming to enhance the design, implementation, analysis and reporting of PROs in trials and to improve the way that PRO results are used to inform clinical care. Recent success includes the development of the new CONSORT PRO extension which provides guidance for reporting PRO trial results http://www.consort-statement.org/

pros-edited

Specifically, the PRO research group focuses on the development of best practice in the following areas:

  1. Trial Design and Protocol Development
  2. Implementation of PROs in Clinical Trials 
  3. Reporting of trials where PROs are an outcome
  4. Use of PRO trial data to inform clinical care

The cross cutting themes underpinning this work are ‘ethics, education, training and knowledge transfer’ for clinicians, researchers, policymakers, patients and carers.

Related activities

Members of the PROs Research Group are involved in the ‘International Society for Quality of Life Research (ISOQOL). Best practices for PROs in Randomized Clinical Trials Task Force’ http://www.isoqol.org/ The PRO Research Group is also involved in broader outcomes research.

Dr Melanie Calvert is an expert advisor on PROs for the NIHR West Midland Research Design Service  and leads the outcomes research work stream within the MRC Midland Hub for Trials Methodology research. Researchers at the University of Birmingham are actively engaging with the COMET initiative. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative which brings together people interested in the development and application of agreed standardised sets of outcomes, known as ‘core outcome sets’”.  These sets will make it easier for researchers and clinicians to compare results of trials on specific conditions in a standardised way. This encompasses both applied and methodological research.

 

Current projects...

Trial Design and Protocol Development

Evaluation of patient reported outcomes in clinical trials: systematic review of trial protocols
 Investigators: Calvert M (PI), Kyte D, Draper H, Ives J, Gheorge A, Brundage M, King M, Mercieca-Bebber R, Blazeby J.Funder: NIHR NSPCR

Centre selection for clinical trials and the generalisability of results: a mixed methods study
Investigators: Gheorghe A, Roberts T, Ives, J, Fletcher, B, Calvert MFunder: DoH RSF

Implementation of PROs in Clinical Trials

Methodological and ethical issues in health-related quality of life research (ME-QOL)
Doctoral Researcher: Derek Kyte; Supervisors: Calvert M, Draper H, Ives JFunder: NIHR (NSPCR)

Reporting of trials where PROs are an outcome

CONSORT Patient Reported Outcomes; (PRO) Extension
 Investigators: Calvert M (PI), Blazeby J, Brundage M, Moher D, Revicki D
Funder: MRC
In order to improve the reporting of PROs in clinical trials the International Society for Quality of Life Research, MRC Midland and ConDuCT Hubs for Trials Methodology Research and members of the CONSORT Executive have led the development of the CONSORT PRO Extension. The international project has involved a systematic review, survey of key stakeholders (members of the International Society for Quality of Life Research, International Society for Pharmacoeconomics and Outcomes Research, UK and European clinical trials units, the NIHR Research Design Service, MRC Hubs for Methodology Research, the Cochrane PRO Methodology Group, NETSCC and NICE Appraisal Chairs) and a Consensus Meeting. The guidance will complement the existing CONSORT recommendations http://www.consort-statement.org/ and will be featured on the website of the EQUATOR network http://www.equator-network.org/.

Knowledge to action: Knowledge translation activities relating to the CONSORT PRO Extension
Investigators Brundage M (PI), Blazeby J, Calvert M, de Vet HCW, Efficace F, Moher D, Revicki D, Scott J, Snyder C, Yount SFunder: CIHR

Use of PRO trial data to inform clinical care

Oncologists attitudes to the use of PRO trial data to inform clinical practiceMasters Research: Student: Julie Rouette J; Supervisor Brundage MExpert International Advisory Group: Calvert M, Blazeby J, King M, Ringash J, Meyer R.

Recent publications...

1. Calvert M, Blazeby J, Revicki D, Moher D, Brundage M. Improving health-related quality of life reporting in clinical trials: why do we need a CONSORT extension? Lancet. 2011 Nov 12;378(9804):1684-5.

2. Brundage M, Blazeby J, Revicki D, Bass B, de Vet H, Duffy H, Efficace F, King M, Lam C, Moher D, Scott J, Sloan J, Snyder C , Yount S, Calvert M Patient-reported outcomes in randomized clinical trials: development of ISOQOL reporting standards Qual Life Res DOI 10.1007/s11136-012-0252-1 Published online 18 Sept 2012.

3. Calvert M, Blazeby J, Altman D, Revicki,D, Moher D, Brundage M on behalf of the CONSORT PRO Group. Improving the Reporting of Patient Reported Outcomes in Randomised Trials: the CONSORT PRO Extension (under review)

4. Kyte D, Draper H, Ives J, Liles C, Gheorghe A, Calvert M. Collection of Patient Reported Outcomes (PROs) in Clinical Trials: Is ‘In-Trial’ Guidance Lacking? A Systematic Review Employing Qualitative Content Analysis (under review)

5. Gheorghe A, Roberts T, Ives J, Fletcher B, Calvert M. Centre selection for clinical trials and the generalisability of results: a mixed methods study. PLOS One (in press)

Research group members...

Group lead: Dr Melanie Calvert [m.calvert@bham.ac.uk], Reader in Epidemiology
Deputy lead: Mr Derek Kyte
Researchers: Prof Heather Draper, Dr Jon Ives
Doctoral Researchers: Adrian Gheorghe, Derek Kyte
Research Officer: Helen Duffy

Collaborators:
University of Birmingham
Prof Tracy Roberts, Prof Dion Morton, Prof Paulus Kirchhof, Prof Jon Deeks, Prof Helen Lester, Dr Paramjit Gill, Dr Alison Rushton, Dr Paul Cockwell, Mr Ben Fletcher

West Midlands Research Collaborative: including Thomas Pinkney, David Bartlett and Haney Youseff, William Hawkins http://www.wmresearch.org.uk/

UK
Prof. Doug Altman, Centre for Statistics in Medicine, Oxford #
Prof. Richard McManus, Oxford
Prof. Jane Blazeby, MRC ConDuCT HTMR, Bristol*#
http://www.bristol.ac.uk/social-community-medicine/centres/conduct/  
Prof. Nick Freemantle, UCL.
Prof. Paula Williamson, MRC Northwest Hub for Trials Methodology research, Liverpool.
Dr Jane Scott, PRO Strategic Relations*#
Dr Peter Davidson, NETSCC, University of Southampton #
Prof. Michael Drummond, Co-Editor-in-Chief , Value in Health #
Prof. Martin Eccles, Newcastle University #
Dr. Astrid James, Deputy Editor, The Lancet #
Dr. Xavier Luria, Head of Safety and Efficacy of Medicines, European Medicines Agency (EMA) #
Mr. Richard Stephens, Patient Representative #
Professor Andrew Stevens, Chair, NICE Appraisals Committee #
Dr. Emma Veitch, Acting Deputy Editor, PLoS Medicine #
Dr. Trish Groves, Deputy Editor / Editor-in-Chief BMJ Open, BMJ #
Ms. Maria Von Hildebrand, Carer Representative #
Mr. Richard Haslop, Research Associate, UCL

International Collaborators
 Prof. Michael Brundage, Queen’s University, Canada* #
Prof. David Moher, Ottawa Hospital Research Institute, Canada*#
Prof. Dennis Revicki, United Biosource Corporation, USA*#
Dr Fabio Efficace, GIMEMA, Italy*#
Prof. Henrica de Vet, VU University Medical Centre, The Netherlands*#
Prof. Susan Yount, North Western University Feinberg School of Medicine, USA*#
Prof. Claire Snyder, Johns Hopkins Medicine, USA*#
Prof. Madeleine King, University of Sydney, Australia*#
Prof. Cindy Lam, The University of Hong Kong, Hong Kong*#
Dr. Cynthia J. Girman, Senior Director, Department of Epidemiology, Merck Research Laboratories, USA,
Dr. Robert M. Golub, Deputy Editor, JAMA, USA #
Professor. Paul B. Jacobsen, Associate Editor, JCO, USA #
Dr.Ethan Basch, Associate Attending Physician and Health Services Researcher, Memorial Sloan-Kettering Cancer Center, USA #
Professor Donald Patrick, Professor and Board of Director Member, ISPOR, USA #
Dr. Sharon Straus, Director, Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Canada #
Associate Professor Rosalie Viney, Deputy Director, Centre for Health Economics Research and Evaluation, University of Technology Sydney, Australia #
Dr. Deborah Watkins Bruner, Robert W. Woodruff Professor of Nursing, Emory University, USA #

* ISOQOL Taskforce members
# Collaborators on the CONSORT PRO Extension

CONSORT PRO Executive
 Prof. Michael Brundage, Queen’s University, Canada* #
Prof. Jane Blazeby, MRC ConDuCT HTMR, Bristol*#
Dr. Melanie Calvert, University of Birmingham *#
Prof. David Moher, Ottawa Hospital Research Institute, Canada*#
Prof. Dennis Revicki, United Biosource Corporation, USA*#
Prof. Doug Altman, Centre for Statistics in Medicine, Oxford #

Useful links...

News...

CONSORT PRO Extension Published in JAMA

 A successful collaboration between the MRC Midland and ConDuCT Hubs for Trials Methodology Research, UK, ISOQOL Reporting Guidelines Taskforce and the CONSORT Executive has led to the new CONSORT PRO Extension being published in JAMA. The new guidance informed by key international stakeholders aims to facilitate the transparent reporting of PRO data from trials to inform patient care and health policy.

Calvert M, Blazeby J , Altman D , Revicki D , Moher D, Brundage Reporting of Patient Reported Outcomes in Randomised Trials: the CONSORT PRO Extension. JAMA 2013; 309 (8) 814-822 http://jama.jamanetwork.com/article.aspx?articleid=1656259

http://www.birmingham.ac.uk/news/latest/2013/02/27-Feb-New-guidance-urges-improved-reporting-of-important-outcomes-for-patients-in-trials-publications.aspx


Centre selection for clinical Trials

 The results of the group's research on centre selection in RCTs have now been published in PLOS One. Using a mixed methods study comprising a systematic review of NIHR HTA-funded RCTs, focus groups with trialists and an electronic survey of CRCUK Clinical Trials Units, we mapped the considerations that trialists account for when including centres in RCTs. We found that generalisability often plays only a small role in this process at the detriment of pragmatic issues, thus threatening the external validity of trial findings. The potential impact of this practice on the generalisability of trial-based cost-effectiveness results and possible ways forward will be the subject of a panel at the ISPOR (International Society for Pharmacoeconomics and Outcomes Research) Annual Meeting in New Orleans, USA (May 2013), where Adrian Gheorghe will join a panel of prominent health economists in discussing the issue.

Gheorghe A, Roberts TE, Ives JC, Fletcher BR, Calvert M (2013) Centre Selection for Clinical Trials and the Generalisability of Results: A Mixed Methods Study. PLoS ONE 8(2): e56560. doi:10.1371/journal.pone.0056560. http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0056560